nazorg na hartcatheterisatie en percutaan coronair interventie closure artery transradial access
Conditions
Interventions
The research treatment concerns the duration of R band with StatSeal after a
coronary angiography and/or percutaneous coronary intervention, the 2 hour
protocol of R band is the standard protocol an
Sponsors
HagaZiekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: the subject is 18 years or older the subject has given informed consent the subject is planned for a diagnostic coronair angiography and/or (planned or acute or urgent) percutaneous coronair intervention
Exclusion criteria
Exclusion criteria: the subject has received Rheopro or bivaluridin iv during the CAG/PCI the coronair angiography and/or percutaneous coronair intervention isn't performed through the artery radialis;the subject has a AV shunt for kidneydialysis or is a candidate for this the subject has a known pathology of artery of the upper body or subclavia the subject is incapable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occlusion: will be measured using a mobile Doppler ultrasound device. This will be done after removing the R band and when the patient is visiting the out-patient department. the primary study parameter discomfort: will be described and measured on a scale from 1 to 5 (5 serious, 4 considerable, 3 moderate, 2 a little,1 no discomfort) at arrival on the CCU/CL after CAG/PCI, after removing the R band and during the out patient department visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding complication: bleeding complication is defined as signs of bleeding from the radial artery where medical intervention is directly needed. Medical intervention of a R band or reapplication of the R band as a result of bleeding after earlier deflation according to the protocol or a decline in Hb of more than 3 g/dl from a hematoma of more than 5 cm will be seen as a complication. Pain: pain will be measured using the Visual analogue scale from 1-10 at arrival on the CCU/CL after CAG/PCI, after removing the R band and on the firts out-patient department visit. Discomfort: will be measured on a scale from 1 to 5 (5 serious, 4 considerable, 3 moderate, 2 a little,1 no discomfort) at arrival on the CCU/CL after CAG/PCI, after removing the R band and on the firts out-patient department visit. Duration hospital stay: will be measured in minutes from the moment the R band is placed after a CAG/PCI until discharge from the hospital. Use of number of different coagulantia: the total number of different coagulantia will noted before CAG/PCI until the last follow up control (on the firts out-patient department visit) Costs used material for radial artery compression: the number of used R bands and/or Staseal will be registered. The purchase price, inclusive sales tax, of the R band and Statseal will be collected and added up toghether. Costs complication treatment: all used material, bloodproducts, medication, consultation, possible surgical intervention and diagnostic examination to investigate or treat the complication of the radial artery compression will be collected from Hix and calculated, inclusive sales tax. | — |
Countries
Netherlands
Outcome results
None listed